FDA.reportPublic FDA data

Reach Needle

Primary DI
28886479300256
Brand
Reach Needle
Company
Aerin Medical Inc.
Model
CAT1614-05
Catalog number
CAT1614-05
Device description
Single use anesthesia needle
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240253000Reach NeedleAerin Medical, Inc.2024-03-21BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28886479300256PackageGS15In Commercial Distribution
08886479300252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2888647930025628886479300256
08886479300252088864793002528886479300252

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833-484-8237customerservice@aerinmedical.com

Regulatory Flags#

DUNS number
051512253
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08886479300306RhinAer+ StylusFG2258CAT22592025-09-19
08886479300023InSeca ARC StylusFG256CAT4092017-12-19
08886479300146Vivaer ARC StylusFG257CAT4102017-12-19
08886479300160VivAer® StylusFG722CAT7232020-10-19
08886479300184RhinAer StylusFG815CAT8212020-02-03
08886479300269VivAer® StylusFG1787CAT17852024-01-05
08886479300030Aerin ConsoleFG226CAT3052017-12-19
08886479300238RhinAer® StylusFG1393CAT13942022-08-19
08886479300047Aerin Console SetCAT305CAT305-022017-12-19
08886479300283Aerin ConsoleFG2045CAT20462024-12-18
08886479300290Aerin Console SetFG2045CAT2046-012024-12-18
08886479300252Reach NeedleCAT1614-05CAT1614-052024-06-10
08886479300108Power Cord (OUS)MS589CAT309-012023-10-19
08886479300122Power Cord (UK)MS588CAT309-032023-10-19
08886479300207Power Cord (OUS) 15 FTMS1222CAT309-042023-10-19
08886479300221Power Cord (UK) 15 FTMS1223CAT309-062023-10-19
08886479300115Power CordCAT309-02CAT309-022017-12-19
08886479300139Foot SwitchCAT307CAT3072017-12-19
08886479300214Power Cord 15 ft (US)MS1198309-052021-07-15
28886479300157Sterile Aquasonic 100 Ultrasound Transmission GelMS303CAT447-Q062017-12-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M661S103418350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S103418500Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C21600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
08886479300252Reach NeedleAerin Medical Inc.BSP2024-06-10
M661S80C21200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
M661S80C21400MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
10193489250428Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489250510Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489778083Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489902822Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10612479261003McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261034McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261065McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261096McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261126McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261157McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10193489253023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2021-08-27
10193489550115MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-28
10193489270990MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-27
10680651479096HalyardAvanos Medical, Inc.BSP2019-07-15
10680651477566HalyardAvanos Medical, Inc.BSP2019-06-15
10680651478181HalyardAvanos Medical, Inc.BSP2019-06-15
10680651478785HalyardAvanos Medical, Inc.BSP2019-06-15
10680651476439HalyardAvanos Medical, Inc.BSP2019-02-21
10680651477061HalyardAvanos Medical, Inc.BSP2019-02-21